Actively Recruiting
Cardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial
Led by Aventyn, Inc. · Updated on 2026-02-12
300
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Aventyn, Inc.
Lead Sponsor
D
Dignity Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an AI-based treatment strategy using a Chatbot, Copilot, large language models, and vital sign monitoring devices to reduce the burden of Cardio Kidney Metabolic (CKM) diseases. This study focuses on patients with interconnected conditions including diabetes, heart disease, and kidney disease, which have significant health and economic impacts. The trial aims to use an algorithm derived from biomarkers and diagnostics combined with remote sensor technology and patient empowerment to improve health outcomes in this population. Participants will be assigned randomly to either an intervention group receiving the CHAPERONE AI treatment or a control group. The intervention uses machine learning-based Chatbot and Copilot tools along with algorithms informed by biomarkers and diagnostics to manage CKM diseases. The study will assess outcomes at 30, 90, and 180 days, including reduction in kidney failure progression, heart failure events, acute myocardial infarction, diabetes complications, hospitalizations, and mortality. Additional tools such as the CKMiq AI device will be used to monitor cardiovascular readmissions and patient well-being through established scoring systems. During the trial, participants will undergo assessments of their health status, including biomarker analysis, diagnostic tests, and quality of life surveys like the SF-12. Researchers will monitor composite outcomes related to kidney and heart disease progression and hospital readmissions. Data will be collected at multiple time points to evaluate the impact of the AI-driven intervention on disease management and patient empowerment over six months. Safety and health status will be followed up for the duration of participation, which begins at enrollment and continues through 180 days.
CONDITIONS
Brief Title
Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over 18 years of age
- Diagnosed with one or more of the following: diabetes with A1C of 7.5 or higher, heart disease with stent placement, coronary artery bypass graft (CABG) in the last 12 months, or chronic kidney disease stage 2 to 4
- For heart failure patients, hospitalization within one week before enrollment is required
You will not qualify if you...
- Not willing to sign an informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 180 days
Participants receive an AI and algorithm-based intervention designed to reduce progression of cardio kidney metabolic diseases, improve health outcomes, and reduce hospital readmissions.
Visits at 30 days, 90 days, and 180 days
Trial Site Locations
Total: 5 locations
1
Fountains Family Care
Chandler, Arizona, United States, 85248
Completed
2
Gilbert Cardiology
Gilbert, Arizona, United States, 85297
Actively Recruiting
3
Arizona Heart Foundation
Phoenix, Arizona, United States, 85014
Actively Recruiting
4
East Valley Diabetes
San Tan Valley, Arizona, United States, 85143
Completed
5
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
Research Team
N
Navin Govind Steering Committtee, MS
A
Aditya Vijay, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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